MAUDE Adverse Event Report: UNKNOWN SIGNATURE CARE MENSTRUAL PADS; PAD, MENSTRUAL, UNSCENTED

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Skin Inflammation/ Irritation (4545)

Event Date 03/03/2023

Event Type  Injury  

Event Description

Attention due too its content this message is to be seen by females only!!! on (b)(6) 2023 i had purchased a pack with 28 pads (sanitary napkins) from the brand named signature care at (b)(6).Indeed i did not use them till (b)(6) 2023 and (b)(6) 2023 and they had a chemical plasticky odor on them which made me nauseated while i used them and they gave me irritations at the genital area and i stopped using as of (b)(6) 22023.Please inspect this brand and other products at (b)(6) for some reasons seems like no one is inspecting our products anymore and there are always issues that are giving a bad impact in our health.Also they have the legs of an woman exposed at their plastic cover and we do not need those images neither, see if you can bring that at their attention.Indeed we need information like on where to report if something is wrong with these products.For example they can type there if something is wrong with these product and the issue is bot resolved by calling us then please feel free to report it to med watch/fda's website.Upc bar code is (b)(4) and this one is distributed by (b)(4) is written in very small numbers that are hard to see.Please bring this issue to them too.

• Brand Name: SIGNATURE CARE MENSTRUAL PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16505416
• MDR Text Key: 311042321
• Report Number: MW5115562
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White